(223 days)
The TechLab Crypto/Giardia-Cel IF Test can be used to detect Cryptosporidium oocysts and Giardia cysts in fecal specimens from persons suspected of having intestinal disease due to these pathogens.
The kit, which includes ready-to-use reagents, contains an antibody reagent consisting of a mixture of FITC-labeled anti-Cryptosporidium monoclonal antibody and FITC-labeled anti-Giardia monoclonal antibody. These antibodies function as the detecting antibodies. The monoclonal antibodies are prepared from mouse ascites fluid. The antibodies against Giardia are the same as those used in the Giardia-Cel IF Test (K912152), which has been cleared for in vitro diagnostic use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TechLab Crypto/Giardia-Cel IF Test:
While the provided text describes the device and its intended use, it does not explicitly state specific numerical acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. Instead, it focuses on demonstrating "substantial equivalence" to existing cleared devices by showing a "correlation of 100%." This implies that the acceptance criteria are met if the new test performs identically to already approved tests.
Here's the information extracted and organized based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to approved immunofluorescent test specific for Cryptosporidium and Giardia (Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure). | 100% correlation with the Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure in two studies for the detection of Cryptosporidium oocysts and Giardia cysts in fecal specimens. |
| Substantial equivalence to the Giardia-Cel IF Test (approved for in vitro diagnostic use) and the Crypto-Cel IF Test (510(k) application submitted). | 100% correlation with the Giardia-Cel IF Test and the Crypto-Cel IF Test in one of the studies. |
Study Details
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Sample size used for the test set and the data provenance:
- The text does not specify the exact sample size used for the test set in either of the two studies.
- Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "clinical evaluations," which typically suggests patient samples, but further details are not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The text does not mention the use of experts to establish ground truth or their qualifications. The ground truth appears to be established by comparison with existing cleared diagnostic tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The text does not describe an adjudication method. The study design is a head-to-head comparison with established tests, implying the results of the comparator tests served as a reference.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test, not an AI-powered image analysis tool. The study focuses on the performance of the test itself, not on human reader improvement with AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was effectively done. The study compared the TechLab Crypto/Giardia-Cel IF Test directly against other diagnostic tests. The "performance" being measured is the inherent capability of the test reagents and methodology to detect the pathogens, independent of human interpretation variability once the fluorescence is observed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by comparison with FDA-cleared and submitted diagnostic tests (Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure, Giardia-Cel IF Test, and Crypto-Cel IF Test). The assumption is that these comparator tests accurately identify the presence of Cryptosporidium oocysts and Giardia cysts.
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The sample size for the training set:
- The text does not refer to a "training set" as this is a traditional laboratory diagnostic test rather than a machine learning algorithm. Therefore, no sample size for a training set is mentioned or applicable in this context.
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How the ground truth for the training set was established:
- As no "training set" is applicable for this type of IVD, this question is not relevant to the provided information.
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SUMMARY OF SAFETY AND EFFECTIVENESS
- Name of Manufacturer
TechLab, Inc. Corporate Research Center 1861 Pratt Drive Blacksburg, VA 24060
AUG - 5 1996
- Establishment Registration
Federal ID # 54-1527427 Initial Registration of Medical Device Establishment, #1122855
- Trade Name
Crypto/Giardia-Cel IF Test
- Common Name
Cryptosporidium and Giardia Immunofluorescent Test
- Class of Device
This device is classified in Class I.
- Performance Standards
No performance standards have been developed for this device under 514 of the Food, Drug, and Cosmetic Act.
7. Safety and Effectiveness
The TechLab Crypto/Giardia-Cel IF Test can be used to detect Cryptosporidium oocysts and Giardia cysts in fecal specimens from persons suspected of having intestinal disease due to these pathogens. The kit, which includes ready-to-use reagents, contains an antibody reagent consisting of a mixture of FITC-labeled anti-Cryptosporidium monoclonal antibody and FITC-labeled anti-Giardia monoclonal antibody. These antibodies function as the detecting antibodies. The monoclonal antibodies are prepared from mouse ascites fluid. The antibodies against Giardia are the same as those used in the Giardia-Cel IF Test (K912152), which has been cleared for in vitro diagnostic use.
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The Crypto/Giardia-Cel IF Test is to be used in an immunofluorescent assay and is substantially equivalent to an approved immunofluorescent test that also is specific for Cryptosporidium and Giardia. Both of these tests serve as diagnostic aids for cryptosporidiosis and giardiasis by detecting the organism or its antigens.
The TechLab Crypto/Giardia-Cel IF Test was compared in two studies with the Merifluor Cryptosporidium/Giardia Direct Immunofluorescent Detection Procedure (Meridian Diagnostics, Inc., Cincinnati, OH) for the detection of these organisms in fecal specimens. In addition, the TechLab test was compared in one of the studies with the Giardia-Cel IF Test, which has been approved for in vitro diagnostic use, and with the Crypto-Cel IF Test, for which we have submitted a 510(k) application. The results of our clinical evaluations show that the TechLab Crypto/Giardia-Cel IF Test exhibits a correlation of 100% when compared with these tests. These results show that the TechLab Crypto/Giardia-Cel IF Test is useful for the detection of these pathogens in fecal specimens.
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.